MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS GS PREMIUM; ANESTHESIA UNITS

Model Number	8607000
Medical Device Problem Codes	Gas Output Problem (1266); Decreased Pump Speed (1500); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that mechanical ventilation failed during use.The device generated a corresponding alarm.There was no injury reported.
Additional Manufacturer Narrative
The investigation is ongoing.We will provide results with a separate follow-up report.
Additional Manufacturer Narrative
Based on the log analysis, the reported vent fail could be confirmed.It was found that the device has shut down automatic ventilation due to measured speed fluctuations at the ventilator.This is a safety measure to prevent from potentially hazardous output and/or from damages to the ventilator unit.The user is alerted to the shutdown of automatic ventilation by a corresponding alarm.Manual ventilation remains possible, and monitoring is still functional.During on-site examination of the device in question performed by the draeger service technician, the reported issue could not be duplicated.Since the found logfile entries point to an issue with e.G.The ventilator unit, the motor, light barrier or incrementer, the ventilator assembly was requested for a detailed investigation at the manufacturer¿s lab.Unfortunately, however, the part was not made available.Therefore, the exact root cause could not be finally determined.Since the draeger technician could not duplicate the issue and no malfunctions were detected either, it could be concluded that most likely a temporary issue was the root cause.Dräger finally concludes that the device behaved as specified upon the detected speed fluctuations at the ventilator; no patient consequences have been reported.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
Event or Problem Description
It was reported that mechanical ventilation failed during use.The device generated a corresponding alarm.There was no injury reported.

• Brand Name: FABIUS GS PREMIUM
• Common Device Name: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 20967036
• Report Number: 9611500-2024-00589
• Device Sequence Number: 15565131
• Product Code: BSZ
• UDI-Device Identifier: 04048675041467
• UDI-Public: (01)04048675041467(11)190411(93)8607000-73
• Combination Product (Y/N): N
• PMA/510(K) Number: K011404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8607000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown